Therapy for neurological diseases

Abstract

A dosage form is disclosed for administering 10 ng to 1200 mg tacrine to a patient in need of tacrine therapy.

Description

This invention pertains to therapy indicated for the management of neurological diseases. More particularly, the invention relates to a dosage form that provides a controlled delivery of tacrine over an extended time for the treatment of neurological diseases, including Alzheimer's disease. The invention concerns additionally a therapeutic composition of matter comprising tacrine useful for treating neurological diseases, including Alzheimer's disease. The invention relates further to a method of administering tacrine to produce a beneficial effect for treating neurological diseases, including Alzheimer's disease.The drug tacrine is indicated for the treatment of neurological diseases, including Alzheimer's disease. The neurological-Alzheimer's disease is a progressive, irreversible brain disorder that strikes more frequently with advancing age. The common symptoms of this neurological disease generally include memory loss, confusion, impaired judgment, personality changes, and the ...

AI Technical Summary

Benefits of technology

Another object of the present invention is to provide a dosage form for orally administering tacrine to a patient in need of tacrine at a controlled-rate, in an extended-therapeutic dose, over an extended period of time.

The present invention manufactures a dosage form caplet 10 by surrounding a pressed solid caplet-shaped solid body 11 with a semipermeable wall 12, or first with inner coat 39 followed by a semipermeable wall 12. One method of manufacture comprises inserting a pressed body into a caplet channel machine leaving one end exposed, which is dipped into wall-forming bath to coat the exposed end, followed by dipping the other uncoated end into the bath to surround the end with a wall-forming composition. In one manufacture, the caplet is coated with a semipermeable wall and then permitted to dry with rotation for evenly spreading the wall-forming semipermeable wall around the body of the caplet. In another manufacture, a subcoat is applied to the body of the caplet. Next, after the caplet is permitted to dry it is followed by coating the body of the caplet in a semipermeable wall-forming bath. Inner coat 39, in this manufacture, serves as a lubricating coat to facilitate high drug loading of caplet 10 and to facilitate the uninhibited delivery of tacrine 16 from dosage form caplet 10. That is, by lubricating wall 12, it substantially eliminates internal resistance of tacrine delivery from caplet 10.

Problems solved by technology

The conventional forms deliver the drug by dose-dumping, and this leads to uneven dosing of drug, to uneven blood levels of the drug characterized by peaks and valleys, and accordingly, this does not provide controlled-rate therapy over an extended period of time.

The drug tacrine, however, possesses a low osmotic pressure, which dictates against providing an osmotic dosage form for use in the gastrointestinal tract.

The gastrointestinal tract has a high osmotic pressure, and this speaks against an osmotic dosage form comprising tacrine as this environment can adversely affect the delivery of tacrine, from the dosage form in this environment.

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